Pen Needle Dispensing Apparatus

ABSTRACT

An apparatus is disclosed for storing and dispensing a pen needle for an injection device, including a packaging assembly including a pliable outer cover, the outer cover having a hub portion, a needle portion disposed at a distal end of the hub portion, and a flange disposed at a proximal end of the hub portion, the hub portion having internally protruding splines or other structures for engaging a hub of a pen needle. The hub portion is sufficiently pliable for a user to press gripping portions of the hub portion so that corresponding internal portions of the hub portion between the splines contacts the pen needle hub to increase a surface area contact between the outer cover and a pen needle therein.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.13/198,564, filed on Aug. 4, 2011, which claims the benefit of U.S.Provisional Patent Application Ser. No. 61/344,541, filed on Aug. 16,2010, the disclosures of both of said prior applications beingincorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to needles for a pen injection device, andmore particularly, to an apparatus for dispensing and storing needlesfor a pen injection device.

2. Description of the Related Art

Medication delivery pens are used for self-injection of preciselymeasured doses of medication. Pens are widely used, for example, bydiabetics to self-inject insulin. A typical medication delivery penincludes a cartridge which contains a volume of liquid medicationsufficient for several doses. Using a pen needle attached to the pendevice, the dose is injected into a tissue area, such as theintramuscular tissue layer, the subcutaneous tissue layer, or theintradermal tissue layer.

The assembly and operation of a typical pen injection device isdescribed in commonly-assigned U.S. Pat. No. 7,645,264, which is herebyincorporated by reference in its entirety.

Pen injection devices, such as an exemplary pen injector 50, as shown inFIGS. 1 and 2, typically comprise a dose knob/button 24, an outer sleeve13, and a cap 21. The dose knob/button 24 allows a user to set thedosage of medication to be injected. The outer sleeve 13 is gripped bythe user when injecting medication. The cap 21 is employed by the userto securely hold the pen injector 50 in a shirt pocket, purse, or othersuitable location.

FIG. 2 is an exploded view of the exemplary drug delivery pen 50 shownin FIG. 1. The dose knob/button 24 has a dual purpose and is used toboth set the dosage of the medication to be injected and to inject thedosed medicament via a lead screw 7 and stopper 15 from a medicamentcartridge 12, which is attached to the drug delivery pen through a lowerhousing 17. The medicament cartridge 12 is typically a glass tube sealedat 1 end with a septum 16 and at the other end with the stopper 15. Instandard drug delivery pens, the dosing and delivery mechanisms are allfound within the outer sleeve 13. Those mechanisms are not described ingreater detail herein as they are understood by those knowledgeable ofthe art.

A pen needle assembly 10 includes a hub 20, a patient needle 11extending from a patient end of the pen needle assembly, and aseptum-penetrating needle cannula 18 disposed within the hub 20 on anon-patient side thereof. The septum-penetrating needle cannula 18 is influid communication with the patient needle 11. The hub 20 is preferablyscrewed onto the lower housing 17, although other attachment means canbe used such as attaching directly to the medicament cartridge 12. Inattaching the hub 20 to the lower housing 17 or medicament cartridge 12,the septum-penetrating cannula 18 pierces the septum 16, but the septum16 does not move with respect to the medicament cartridge 12. Thestopper 15, however, is axially displaceable within the medicamentcartridge 12 while maintaining a fluid-tight seal. The distal movementof the plunger or stopper 15 within the medicament cartridge 12 (due toadvancement of the lead screw 7) causes medication to be forced into thepatient needle 11 of the hub 20.

To protect a user, or anyone who handles the pen injector 50, a rigidouter shield 29 that attaches to the hub 20, covers the hub 20. Theouter shield 29 can also be used as a handle or grip to screw hub 20onto or off of pen injector 50. Typically, a teardrop cover or label 32,attached to a top flange 30 of the outer shield 29 and having a tab 34for a handle (best shown in FIG. 8), provides a sterility barrier forthe contents of the outer shield 29. An inner shield or needle cover 28covers the patient needle 11 within the outer shield 29. The innershield 28 can be secured to the hub 20 to cover the patient needle 11 byany suitable means, such as an interference fit or a snap fit. The outershield 29 and inner shield 28 are removed prior to use. The cap 21 fitssnugly against outer sleeve 13 to allow a user to securely carry the peninjection device 50.

Pen needle assemblies are usually sold individually packaged inside aplastic cover (such as outer shield 29) with a label covering theopening in the cover to provide a sterility barrier. These individuallypackaged pen needle assemblies are often sold packed loosely in acontainer, such as a box. Boxes of various sizes are used for variousquantities of the individually packaged pen needle assemblies (forexample, a 50 count box or a 100 count box).

SUMMARY OF EMBODIMENTS OF THE INVENTION

It is an aspect of the present invention to provide an apparatus forstoring pen needles. More specifically, it is an aspect of the presentinvention to provide an apparatus for storing pen needles prior to theiruse as well as subsequent to their use. Additionally, it is an aspect ofthe present invention to provide an apparatus for dispensing pen needlesfor use with a pen injection device.

The foregoing and/or other aspects of the present invention are achievedby providing an apparatus for storing and dispensing a pen needle for aninjection device, including a pliable outer covering for storing a penneedle assembly with a sterility barrier having a heat activatedadhesive to bond the sterility barrier with the outer covering. Theouter covering is sufficiently pliable that a user can compress theouter covering to grasp and hold the pen needle assembly stored withinduring attachment of the pen needle assembly to the pen injectiondevice.

The foregoing and/or other aspects of the present invention are alsoachieved by providing an apparatus for storing and dispensing a penneedle for an injection device, including a packaging assembly includinga pliable outer cover, the outer cover having a hub portion, a needleportion disposed at a distal end of the hub portion, and a flangedisposed at a proximal end of the hub portion, the hub portion havinginternally protruding structures for engaging a hub of a pen needle. Thehub portion is sufficiently pliable for a user to press grippingportions of the hub portion so that corresponding internal portions ofthe hub portion between the splines contacts the pen needle hub toincrease a surface area contact between the outer cover and a pen needletherein.

The foregoing and/or other aspects of the present invention are alsoachieved by providing a method of storing and dispensing a pen needlefor an injection device, the method including the operations of pressinggripping portions of a hub portion of a pliable outer cover having a penneedle therein, so that internal portions of the hub portion contact ahub of the pen needle to increase a surface area of contact between thepen needle and the outer cover. The method also includes attaching theinjection device to the hub while pressing the gripping portions, andremoving the pen needle from the outer cover.

The foregoing and/or other aspects of the present invention are alsoachieved by providing a method of packaging a plurality of pen needlesfor an injection device, the method including providing a plurality ofouter covers having needle portions, hub portions, and flanges withseparably joined edges in an array, the outer covers having acorresponding plurality of pen needles disposed therein.

Additional and/or other aspects and advantages of the present inventionwill be set forth in part in the description that follows and, in part,will be apparent from the description, or may be learned by practice ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and/or other aspects and advantages of embodiments of theinvention will become apparent and more readily appreciated from thefollowing detailed description, taken in conjunction with theaccompanying drawings, in which:

FIG. 1 is a perspective view of an exemplary drug delivery pen;

FIG. 2 is an exploded view of the exemplary drug delivery pen of FIG. 1;

FIGS. 3 and 4 are perspective views of a pen needle assembly inaccordance with an embodiment of the present invention;

FIG. 5 is a perspective view of a packaging assembly in accordance withan embodiment of the present invention;

FIG. 6 is a partial plan view of the packaging assembly of FIG. 5;

FIG. 7 is a perspective view in cross-section taken along line 7-7 inFIG. 5 of the packaging assembly of FIG. 5;

FIG. 8 is a perspective view of a typical outer shield for a pen needleassembly of FIG. 3;

FIG. 9 is a perspective view of the packaging assembly of FIG. 5;

FIG. 10 is a partial perspective view of an alternative sterilitybarrier configuration for the packaging assembly of FIG. 5;

FIG. 11 is a partial perspective view of another alternative sterilitybarrier configuration for the packaging assembly of FIG. 5;

FIG. 12 is a perspective view of a packaging array of a plurality ofpackaging assemblies of FIG. 5; and

FIGS. 13 and 14 are side elevation views illustrating nesting of aplurality of arrays of FIG. 12.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION

Reference will now be made in detail to embodiments of the presentinvention, examples of which are illustrated in the accompanyingdrawings, wherein like reference numerals refer to the like elementsthroughout. The embodiments described herein exemplify, but do notlimit, the present invention by referring to the drawings. As will beunderstood by one skilled in the art, terms such as up, down, bottom,and top are relative, and are employed to aid illustration, but are notlimiting.

FIGS. 3 and 4 are perspective views of a pen needle assembly 10 inaccordance with an embodiment of the present invention. For brevity, thephrase “pen needle 10” will be used hereinafter instead of “pen needleassembly 10.” As shown in FIG. 3, the pen needle 10 includes a hub 20disposed at a non-patient end thereof. The hub 20 includes a pluralityof ribs 64 for engagement with anti-rotation/retaining structures thatwill be described in greater detail below. In addition, protrusion 68extends from a patient end of the hub 20 and the patient needle 11extends from the protrusion 68. The septum-penetrating needle cannula 18(best shown in FIG. 4) disposed within the non-patient end of the hub 20fluidly communicates with the patient needle 11. Further, as shown inFIG. 4, the interior of the non-patient end of the hub 20 includesthreads 72 for connection with an injection device, such as the peninjector 50. For brevity, hereinafter, the pen injector 50 will beemployed as an exemplary injection device. One skilled in the art,however, will appreciate that other injection devices may be usedwithout departing from the scope of the present invention.

FIG. 5 is a perspective view of a packaging assembly 100 in accordancewith an embodiment of the present invention. As shown in FIG. 5, apackaging assembly 100 includes a pliable blister-pack or outer cover104 for storing a pen needle 10 therein. The outer cover 104 includes ahub portion 108 and a needle portion 112. According to one embodiment,the material for the pliable outer cover 104 can be a pliabletransparent plastic material, such as standard medical grade PETGcopolyester having a thickness in the range of about 0.025″ to 0.035″(0.635 mm to 0.890 mm), for example, preferably about 0.030″ (0.760 mm).One of ordinary skill in the art will understand that other materialsmay be used without departing from the scope of the invention. Accordingto one embodiment, as shown in FIG. 5 an inner shield 28 covers apatient needle 11 within the outer cover 104.

The packaging assembly 100 also includes a sterility barrier 116 that isat least partially removable for accessing the pen needle 10. Accordingto one embodiment, the material for the sterility barrier 116 can besurgical grade kraft-paper having a thickness in the range of about0.005″ to 0.020″ (0.125 mm to 0.508 mm), for example, preferably 0.013″(0.330 mm). One of ordinary skill in the art will understand that othermaterials may be used without departing from the scope of the invention.

FIG. 6 is a partial plan view of the packaging assembly 100. FIG. 7 is aperspective view in cross-section taken along line 7-7 in FIG. 5 of thepackaging assembly 100. As shown in FIG. 6, the hub portion 108 of thepackaging assembly 100 for holding a hub 20 of the pen needle assembly10 preferably includes a plurality of splines 120 for holding the hub 20and preventing the pen needle 10 from moving freely within the outercover 104. These splines may be formed by molding, thermoforming, orother methods. In the embodiment illustrated in FIGS. 6 and 7, theneedle portion 112 is substantially frustoconical, the hub portion 108is substantially cylindrical, and a shoulder portion 110 is disposedbetween the needle portion 112 and the hub portion 108 for limiting aninsertion depth of the pen needle 10.

Additionally, as shown in FIG. 6, adjacent to the splines 120, the hubportion 108 includes a plurality of gripping portions 124. As shown inFIGS. 6 and 7, and as will be described in greater detail below, thegripping portions 124 are spaced apart from the hub 20 such that gaps128 exist between the gripping portions 124 and the hub 20.

Patients with diabetes, for example, may demonstrate a reduction intactile abilities of the fingers known as peripheral neuropathy, whichmay increase in intensity as the disease progresses. This can result inthe patient's inability to easily connect the pen needle 10 onto aninjection device, such as the pen injector 50. Similarly, peripheralneuropathy may inhibit the patient's ability to easily remove the penneedle 10 from the pen injector 50.

Materials for a typical rigid outer shield 29 include polypropylene (PP)or polyethylene (PE). When attempting to connect a pen needle 10 ontothe pen injector 50, the patient typically touches only the rigid,usually opaque, outer shield 29, which may feel slippery to the patient.

In contrast to the outer shield 29, because the outer cover 104 can besignificantly more pliable, the outer cover 104 can provide greatertactile feedback for the user, enabling a greater amount of control ofthe pen needle 10 while the patient connects the pen needle to the peninjector 50. For example, when squeezing the hub portion 108 whileturning it, radial torque is transferred directly to the hub 20 by atleast the splines 120. Because of the pliability of the hub portion 108,the patient can more easily determine the force required to squeeze thehub portion 108 to prevent rotation of the pen needle 10 when connectingthe pen needle 10 to the pen injector 50.

Further, because of the splines 120 and the gaps 128, when the patientgrasps and squeezes the gripping portions 124 of the hub portion 108,the splines 120 contact the hub 20 with greater force and internalportions of the pliable hub portion 108 between the splines 120 collapseagainst the hub 20, increasing the surface area contact between the hubportion 108 and the hub 20. The increase in the surface area contactresults in greater frictional resistance between the outer cover 104 andthe pen needle 10, thereby allowing the patient to more easily gauge theamount of pressure required to prevent rotational movement of the penneedle 10 with respect to the outer cover 104 when trying to secure thepen needle 10 to the pen injector 50.

Moreover, the pliability of the needle portion 112 offers anotheradvantage over the outer shield 29 if the patient desires to keep theinner shield 28 within the outer cover 104. After securing the penneedle to the pen injector 50, the patient can grasp the inner shield 28through the needle portion 112 and remove the pen needle 10 whilemaintaining the inner shield within the outer cover. In contrast, therigidity of the typical outer shield 29 does not permit such utility.

The patient also experiences an advantage when removing the pen needle10 from the pen injector 50. Similar to connecting the pen needle 10 andthe pen injector 50, when using a typical outer shield 29, the wall ofthe outer shield 29 is too rigid to be squeezed to any significantextent, causing the patient to rely solely on the fit between the hub 20and the inner surface of the rigid outer shield 29 to provide thenecessary pull force required to pull the septum-penetrating needlecannula 18 from the septum of the medicament cartridge 12. Additionally,the small top flange 30 of the outer shield 29, which is used for labelsealing, provides added rigidity to the outer shield 29.

In contrast, the pliable outer cover 104 may be easily squeezed betweenthe patient's fingertips, the force of which is transferred directlyfrom the inside of the outer cover 104 to the hub 20, allowing foreasier withdrawal of the septum-penetrating needle cannula 18 from theseptum. In other words, when the patient grasps and squeezes thegripping portions 124 of the hub portion 108, the splines 120 contactthe hub 20 with greater force and the pliable hub portion 108 collapsesagainst the hub 20, increasing the surface area contact between the hubportion 108 and the hub 20 and providing a more efficient transfer offorce from the patient's fingers.

The splines 120 are discrete protruding structures that grip and alsoserve a spacing function, i.e., to establish gaps 128. One skilled inthe art will appreciate that the splines 120 may be replaced by otherfeatures, formations, structures, etc. that perform the same functions.

FIG. 8 is a perspective view of a typical outer shield 29 and FIG. 9 isa perspective view of the packaging assembly 100 in accordance with anembodiment of the present invention. As shown in FIGS. 8 and 9, incomparison to the top flange 30 of the outer shield 29, the top flange132 of the outer cover 104 is preferably much larger. Additionally, aswill be discussed in greater detail below, the needle portion 112 of theouter cover 104 is preferably much wider than a needle portion 36 of theouter shield 29.

Patients with reduced tactile abilities can also often experiencedifficulty in removing the sterility barrier (for example, “teardrop”label 32) from the rigid outer shield 29. A typical teardrop label 32used as the sterility barrier for the rigid outer shield 29 has a thinpolyethylene or polypropylene layer on the underside of the label 32.Under intense heat (for example, 400-440° F. (204-227° C.)), the thinlayer on the underside of the label melts onto the flange 30 of theouter shield 29. This plastic to plastic bonding provides a verytenacious grip of the label 32 to the flange 30.

These labels 32 are opened by first pulling on a side tab 34, and thenpulling up on the tab 34. In this manner, the patient has to overcome anespecially heavy label breakout force at the leading edge of the flange30, with only the tab 34 to hold onto with one hand and the oftenslippery PE or PP outer shield 29 with the other. As the label 32continues to be pulled perpendicularly from the flange 30 and approachesthe center of the diameter of the outer shield 29, the required removalforce substantially drops. Then, there is a sudden increase in therequired removal force as the label 32 approaches the trailing edge ofthe flange 30. This may cause over-pulling on the part of the patient,which might cause the outer shield 29 to slip out of the patient's gripand result in a loss of sterility of the pen needle 10.

In contrast, blister-pack labels, such as sterility barrier 116, tend tolend themselves to easy removal due to their reliance on heat-activatedor pressure-sensitive adhesives. These adhesives, particularly whencombined with any number of available label geometry configurationsdesigned specifically for ease of grasping and manipulation, can be agreat benefit to patients with reduced tactical abilities preparing fortheir injections.

In addition, as shown, for example, in FIGS. 6, 7, and 9, thesquared-off flange 132 of the outer cover 104 can provide a largersurface area for sealing than the flange 30 of the outer shield 29. Theflange 132 also provides the patient with additional area to hold thepackaging assembly 100 during label removal and manipulation, as well aspen needle 10 attachment and detachment with respect to the pen injector50. Further, the flange 132 provides increased patient protection andconfidence against accidental needlesticks.

In embodiments of the present invention, a heat-activated orpressure-sensitive adhesive can be used to fasten the sterility barrier116 to the flange 132 of the outer cover 104. An example of such anadhesive can be any medical grade heat-activated epoxy laminate, ofwhich many formulations are available, including Dow Chemical Company'ssolution vinyl resin series of the VCAR, VAGH or VMCH types.

Patients with diabetes and other conditions requiring injectionssometimes suffer from impaired vision, and subsequent hand/eyecoordination issues. According to one embodiment, the outer cover 104 ismanufactured from a material providing a high degree of transparency.Accordingly, the patient can more clearly see attachment of the penneedle 10 onto the pen injector 50 through the wall of the outer cover104. This aids the patient in keeping the central axis of the hub 20 (inother words, the septum-penetrating needle cannula 18) properly alignedwith the central axis of the pen injector 50. This clarity not onlyprovides easier targeting of the hub 20 with respect to the pen injector50, but also helps to prevent the edge of the hub 20 from catching onthe edge of the tip of the pen injector 50 during connection with thepen needle 10.

Further, when removing the pen needle 10 from the pen injector 50, theopacity of the outer shield 29 can sometimes contribute to the exposedpatient needle 11 accidentally penetrating through needle portion 36 ofthe outer shield 29, and thus may produce accidental needlesticks. Incontrast, the clarity of the outer cover 104 is beneficial in targetingthe exposed patient needle 11 into the center of the needle portion 112of the outer cover 104, thereby reducing the possibility of the patientneedle 11 penetrating through the outer cover 104.

Additionally, if the patient maintains the inner shield 28 within theouter cover 104 when removing the pen needle 10 from the outer cover,the clarity of the outer cover aids the patient in fitting the needle 11into the inner shield 28. Likewise, the pliability of the needle portion112 can aid the patient. The user can grasp the larger surface area ofthe needle portion at a distal end thereof, and thereby grip a distalend of the inner shield 28 to maintain the stability of the inner shield28 when inserting the needle 11 therein. By gripping the distal end ofthe inner shield, the patient reduces the risk of needlestick duringinsertion of the needle 11 into the inner shield 28.

Moreover, as shown in FIGS. 8 and 9, the needle portion 112 of the outercover 104 is wider than the narrow profile of the needle portion 36 ofthe outer shield 29. Accordingly, with respect to the needle portion 36,the walls of the needle portion 112 are moved outward, further from theneedle. This also helps to prevent accidental penetration of the patientneedle through the outer cover 104, and thereby helps to protect thepatient's fingers from accidental needlesticks.

Furthermore, the increased size of the flange 132 with respect to theflange 30 and the squared configuration of the flange 132 allows thepatient's fingers to be farther away from the needle portion 112 duringremoval of the pen needle 10 from the pen injector 50, and thus furtherreduces the likelihood of accidental needlesticks. In other words,because of the increased size and the shape of the flange 132, a patientcan grasp the outer cover 104 by opposing edges of the rectangularflange 132, or by opposing faces of the flange 132 (for example, in acorner thereof) during the initial insertion of the pen needle 10 intothe outer cover 104. Subsequently, the user can grasp the grippingportions 124 of the hub portion 108 to increase the surface area contactbetween the hub portion 108 and the hub 20 for removal of the pen needle10 from the pen injector 50.

It is important to the health and safety of each patient that he or shereceive pen needles 10 that are free from critical defects, such as anincomplete sterility barrier. The above-described process forheat-sealing the teardrop labels 32 to the flange 30 of the outer shield29 has tight processing windows, and occasionally delivers weak orincomplete label seals. Although the probability for this to happen islow due to the amount of in-process quality assurance testing that isdone during production, the risk of incomplete sterility barriers stillexists.

In contrast, the ability of blister packaging to eliminate criticalfailures due to weak, faulty, or incomplete seals, has long been knownto medical device manufacturers, as evidenced by the number of blisterpacked syringes and other medical devices that have been successfullyproduced and sold over the years. For example, according to oneembodiment, the sealing of the outer cover 104 by the sterility barrier116 is accomplished using a heat-activated adhesive that is activated ataround 140° F. (60° C.). Thus, ensuring the proper conditions forsterile sealing of the outer cover 104 is less demanding than theconditions required for sterile sealing of the outer shield 29. Further,as an additional benefit to the patient, less force is required to breakthe seal of the adhesive between the sterility barrier 116 and theflange 132 of the outer cover 104 than is required to break the plasticto plastic bond between the teardrop labels 32 and the flange 30 of theouter shield 29.

Referring back to FIG. 5, the illustrated embodiment of the sterilitybarrier 116 is an edge-peel configuration. In other words, to remove thesterility barrier 116 shown in FIG. 5, the patient lifts one edge of thesterility barrier 116 with respect to the flange 132 of the outer cover104. Subsequently, the patient peels back the sterility barrier 116 toreveal the non-patient end pen needle 10. FIGS. 10 and 11 are partialperspective views of alternative sterility barrier configurations. Incontrast to FIG. 5, FIG. 10 illustrates a corner-peel configuration inwhich the patient first lifts a corner of the sterility barrier 116.FIG. 11 illustrates a lift and pull configuration. More specifically,the patient first lifts a flap 136 and then, grasping the flap 136 peelsback the sterility barrier 116 with respect to the flange 132 to revealthe non-patient end of the pen needle 10.

FIG. 12 is a perspective view of a packaging array 140 of a plurality ofpackaging assemblies 100. As shown in FIG. 12, a packaging array 140 isa 4×7 array joining 28 packaging assemblies 100. One of ordinary skillin the art, however, will appreciate arrays of various sizes can be madewithout departing from the scope of the present invention. In FIG. 12,the respective sterility barriers 116 are removed for illustrativepurposes. According to one embodiment, the connection between theindividual packaging assemblies 100 is perforated to ease removal of asingle packaging assembly 100 or a sub-array of packaging assemblies 100from adjoining packaging assemblies 100. Although the flange 132 of theillustrated embodiment is a square parallelogram, one skilled in the artwill appreciate that other shapes may be used without departing from thescope of the invention. For example, the flange may be diamond-shaped,triangular, rectangular, pentagonal, hexagonal, heptagonal, octagonal,or the like. Preferably, the flange is square, rectangular, hexagonal,or octagonal, so that edges of the flange may be joined to minimizewaste and increase packing density. In other words, the flange ispreferably shaped to provide a maximum number of packaging assembliesper volume.

In the packaging array 140 shown in FIG. 12, for added convenience tothe patient, the pen needles 10 are packaged in blister containers orconnected compartments much like typical over-the-counter medications.According to the embodiment shown, up to 28 pen needles may be availableon each “card” or “sheet” or packaging array 140. As such, a supply ofpen needles may be easily and safely transported by the patient insteadof the patient having to carry a shelf carton of loose outer shields 29.

Multiple packaging arrays 140 can then be loaded into a shelf carton.Due to the ability of the packaging arrays 140 to nest (by inverting oneof a pair of packaging arrays 140 so that the respective needle portions112 of the packaging assemblies 100 are adjacent to each other, as shownin FIGS. 13 and 14), utilization of a given space is more efficient. Forexample, a carton containing 112 packaging assemblies 100 in four nestedpackaging arrays 140 can be sized approximately ⅓ smaller than a cartoncontaining 100 loose pack outer shields 29. One of ordinary skill in theart will appreciate that other variations of cartons are possible foradded patient convenience. As an added manufacturing advantage, theconfiguration of the packaging arrays 140 allows the packaging arrays140 to be packaged directly on the assembly line. This eliminates theneed to transport sealed pen needles 10 from the assembly line to thepackaging line during manufacturing, which is one of the primecontributors to prematurely ruptured seals.

Because of the tight operating window of the process for sealing theteardrop labels 32 to the outer shields 29, failures have been known tooccur in the manufacturing process. Though such failures are usuallycaught and inspected out, the process itself and the requireddestructive testing contributes to increased waste and reducedefficiency in manufacturing. One advantage of embodiments of the presentinvention is a manufacturing cost reduction. This cost reduction is dueto the decrease in previously required in-process testing, to assureproper sealing of the label 32 to the flange 30. In manufacturing theouter shield 29, the sample size is large and the in-process testing isperformed often. With the destructive nature of the test, a large amountof good product is destroyed and the associated cost is not recovered.Because of the more easily achieved conditions for manufacturing theembodiments of the present invention described above, sample sizes canbe reduced and/or frequency of testing can be reduced to achieve similarsuccess rates.

An additional advantage of embodiments of the present invention isadditional manufacturing savings due to increased efficiency in the useof materials for sterility barriers. In the manufacturing of the outershield 29, the tear drop labels 32 are held in a web of the samematerial, with the actual labels 32 representing only about 25-30% of aroll of web material. This means that 70-75% of the label 32 materialthat is purchased is discarded as scrap after the teardrop labels 32have been removed from the web. The square shape of the sterilitybarriers 116 in embodiments of the present invention can be moreefficiently manufactured from a roll of material. Not only is the designof the sterility barriers 116 more cost effective, but the design ismore environmentally responsible.

Moreover, during the process of sealing the teardrop labels 32 to theouter shields 29, production must be stopped and the high-temperatureheater heads required for the sealing must be cleaned multiple timesduring each manufacturing shift. Additionally the high-temperatureheater modules must be regularly replaced. Further, the pressurecompliance modules also require a high degree of maintenance. Anotheradvantage of embodiments of the present invention is that the highequipment maintenance costs associated with the process of sealing theteardrop labels 32 to the outer shield 29 is eliminated.

Although only a few embodiments of the present invention have been shownand described, the present invention is not limited to the describedembodiments. Instead, it will be appreciated by those skilled in the artthat changes may be made to these embodiments without departing from theprinciples and spirit of the invention as defined in the appended claimsand their equivalents.

What is claimed is:
 1. A method of packaging a plurality of pen needlesfor an injection device, the method comprising: providing a plurality ofouter covers having needle portions, hub portions, and flanges withseparably joined edges in an array, the outer covers having acorresponding plurality of pen needles disposed therein.
 2. The methodaccording to claim 1, further comprising applying a sheet of sterilitybarrier material to the array.
 3. The method according to claim 2,further comprising: orienting a first array of outer covers in a firstorientation; orienting a second array of outer covers in a secondorientation opposite to the first orientation; and nesting the first andsecond arrays such that at least one of the needle portions of the outercovers in the first array are disposed between a plurality of needleportions of the outer covers of the second array.
 4. The methodaccording to claim 2, further comprising: orienting a first array ofouter covers in a first orientation; orienting a second array of outercovers in a second orientation opposite to the first orientation; andnesting the first and second arrays such that respective needle portionsof the respective arrays of outer covers are adjacent to each other.